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dc.contributor.authorBird, Paul
dc.contributor.authorHall, Stephen
dc.contributor.authorNash, Peter
dc.contributor.authorConnell, Carol A
dc.contributor.authorKwok, Kenneth
dc.contributor.authorWitcombe, David
dc.contributor.authorThirunavukkarasu, Krishan
dc.date.accessioned2020-08-24T01:51:36Z
dc.date.available2020-08-24T01:51:36Z
dc.date.issued2019
dc.identifier.issn2056-5933
dc.identifier.doi10.1136/rmdopen-2018-000742
dc.identifier.urihttp://hdl.handle.net/10072/396673
dc.description.abstractObjectives: Tofacitinib is an oral JAK inhibitor for the treatment of rheumatoid arthritis (RA). We examined response to tofacitinib 5 or 10 mg two times a day in patients with seropositive vs seronegative RA. Methods: Data were pooled from five Phase III studies of conventional synthetic disease-modifying antirheumatic drug (csDMARD)- or biological DMARD-inadequate responders (ORAL Step [NCT00960440]; ORAL Scan [NCT00847613]; ORAL Solo [NCT00814307]; ORAL Sync [NCT00856544]; ORAL Standard [NCT00853385]). 'Serotype' subgroups were: anticyclic citrullinated peptide (CCP) and rheumatoid factor (RF) positive (anti-CCP+/RF+); anti-CCP+/RF negative (-); anti-CCP-/RF+; anti-CCP-/RF-. At month 3, ACR20/50/70 response rates, Disease Activity Score (DAS28-4[ESR])-defined remission (DAS28-4[ESR]<2.6) and low disease activity (LDA; DAS28-4[ESR]≤3.2), changes from baseline (CFB) in Health Assessment Questionnaire-Disability Index (HAQ-DI), Short Form-36 Health Survey (SF-36) physical functioning and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) were evaluated. Safety endpoints were compared. Results: Baseline demographics/characteristics were similar across subgroups. Tofacitinib significantly improved ACR20/50/70 response rates, DAS28-4(ESR) LDA rates and CFB in HAQ-DI and FACIT-F vs placebo across subgroups. More anti-CCP+/RF+ than anti-CCP-/RF- patients had ACR20/50/70 responses (ACR20/50: both tofacitinib doses; ACR70: 10 mg two times a day). SF-36 physical functioning improved in anti-CCP+/RF+, anti-CCP+/RF- and anti-CCP-/RF+ patients (both tofacitinib doses) and anti-CCP-/RF- patients (10 mg two times a day) vs placebo. More anti-CCP+/RF+ and anti-CCP+/RF- than anti-CCP-/RF- patients achieved DAS28-4(ESR) remission and LDA with tofacitinib 10 mg two times a day. Frequency of adverse events (AEs), serious AEs and discontinuations due to AEs were similar across subgroups. Conclusion: Generally, tofacitinib efficacy (ACR20/50/70 responses) and safety were similar across subgroups. DAS28-4(ESR) remission rates and SF-36 physical functioning appeared lower in anti-CCP- patients.
dc.description.peerreviewedYes
dc.languageEnglish
dc.publisherBMJ Publishing Group
dc.relation.ispartofissue1
dc.relation.ispartofjournalRMD Open
dc.relation.ispartofvolume5
dc.subject.fieldofresearchClinical Sciences
dc.subject.fieldofresearchcode1103
dc.subject.keywordsScience & Technology
dc.subject.keywordsLife Sciences & Biomedicine
dc.subject.keywordsRheumatology
dc.subject.keywordsCYCLIC CITRULLINATED PEPTIDE
dc.subject.keywordsJANUS KINASE INHIBITOR
dc.titleTreatment outcomes in patients with seropositive versus seronegative rheumatoid arthritis in Phase III randomised clinical trials of tofacitinib
dc.typeJournal article
dc.type.descriptionC1 - Articles
dcterms.bibliographicCitationBird, P; Hall, S; Nash, P; Connell, CA; Kwok, K; Witcombe, D; Thirunavukkarasu, K, Treatment outcomes in patients with seropositive versus seronegative rheumatoid arthritis in Phase III randomised clinical trials of tofacitinib, RMD Open, 2019, 5 (1)
dcterms.dateAccepted2018-12-03
dcterms.licensehttp://creativecommons.org/licenses/by-nc/4.0/
dc.date.updated2020-08-24T01:48:59Z
dc.description.versionPublished
gro.rights.copyright© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial.
gro.hasfulltextFull Text
gro.griffith.authorNash, Peter


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